Radiation-Free Therapy for the Initial treatment of Good prognosis early non-bulky HL, defined by a low Metabolic Tumor Volume and a negative interim PET after 2 chemotherapy cycles- RAFTING

Trial details

Who runs it

Medical University Of Gdansk

Trial code

EU 2024-515063-66-00

Record updated

2024. november 27.

Original description

To explore the efficacy, in terms of 3-Y PFS of chemotherapy alone in low-risk early-stage I-IIA HL patients, defined by both a low MTV and a negative interim PET after 2 courses of ABVD.Read full original descriptionShow less

Radiation-Free Therapy for the Initial treatment of Good prognosis early non-bulky HL, defined by a low Metabolic Tumor Volume and a negative interim PET after 2 chemotherapy cycles (RAFTING-2019)

To explore the efficacy, in terms of 3-Y PFS of chemotherapy alone in low-risk early-stage I-IIA HL patients, defined by both a low MTV and a negative interim PET after 2 courses of ABVD.

Inclusion: Male or female patients aged 18-70; Total bilirubin must be < 2.0 x the upper limit of normal (ULN) unless known Gilbert syndrome; ALT or AST must be < 3 x the upper limit of normal; Female patients: if postmenopausal for at least 1 year before enrolment or, if fertile - agreeing to practice 2 effective methods of contraception or agreeing to practice true abstinence; Male patients should agree to practice barrier contraception or to practice abstinence; Treatment-naïve, classical HL patients with Ann Arbor stage I or II A non-bulky disease stratified according to modified EORTC Criteria (refer to Appendix A); Patients must have histologically confirmed classical HL according to the current World Health Organization Classification (nodular sclerosis, mixed cellularity, lymphocytes rich, lymphocytes depleted, or classical HL NOS [not otherwise specified]; ECOG performance status 0-2; Hemoglobin must be > 8 gr./dL; Absolute neutrophil count ≥ 1,000/μL; Platelet count ≥ 100,000/μL; Voluntary written consent to take part to the study; Serum Creatinine < 2.0 mg/dL and/or Creatinine clearance or calculated Creatinine clearance > 40 mL/minute.

Exclusion: Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection; Active autoimmune disorder in treatment with immunosuppressive drugs; Myocardial infarction within 2 years of study entry; Bulky disease (Lugano 2014 definition: single or conglomerated nodal mass with the largest diameter measuring 10 or more centimeters); Extra nodal site involved by disease; Uncompensated diabetes mellitus requiring insulin therapy; Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol; Known human immunodeficiency virus (HIV) infection with a positive search for HIV antigens by immunoblot and/or circulating copies of HIV-RNA; Active hepatitis B with circulating copies of HBV-DNA, or active hepatitis C infection with circulating copies of HCV-RNA; Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma; A left-ventricular ejection fraction < 50%; Female patients who are both lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug; Severely impaired, lung and renal function; Pregnancy or lactation; B symptoms.

EU CTIS 2024-515063-66-00